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A Phase 1/2, Open-Label Study Of Neratinib (HKI-272) In Combination With Capecitabine In Subjects With Solid Tumors And ErbB-2 Positive Metastatic Or Locally Advanced Breast Cancer

Phase 1/Phase 2
18 Years
Open (Enrolling)
Breast Cancer

Thank you

Trial Information

A Phase 1/2, Open-Label Study Of Neratinib (HKI-272) In Combination With Capecitabine In Subjects With Solid Tumors And ErbB-2 Positive Metastatic Or Locally Advanced Breast Cancer

Inclusion Criteria:

- Part 1: confirmed pathologic diagnosis of a solid tumor not curable with available
therapies for which neratinib plus capecitabine is a reasonable treatment option.

- Part 2: confirmed histologically and/or cytologically confirmed diagnosis of breast
cancer, metastatic or locally advanced.

- Part 2: erbB-2 gene amplified tumor (FISH or CISH) or erbB-2 overexpression (IHC 3+,
or IHC2+ with FISH or CISH confirmation), based on local testing, or based on
centralized FISH testing prior to day 1.

- Part 2: disease progression on or following at least 1 prior trastuzumab containing
treatment regimen (at least 6 weeks) for metastatic or locally advanced disease.
(Prior adjuvant trastuzumab is allowed but not required). A 2 week period is required
between the last dose of trastuzumab treatment and first dose of the test article.

- Prior treatment with a taxane in the neoadjuvant, adjuvant, locally advanced, and/or
metastatic disease treatment setting.

- Parts 1+2: At least 1 measurable lesion as defined by RECIST criteria.

- Parts 1+2: LVEF within institutional range of normal as measured by multi-gated
acquisition (MUGA) or echocardiogram (ECHO).

Exclusion Criteria:

- Part 2: prior treatment with capecitabine, lapatinib (20 subjects with prior
lapatinib exposure will be enrolled) or any erbB-2 targeted agents except
trastuzumab. Treatment with erbB-2 targeted therapy must exceed 2 weeks (14 days) in
order to be exclusionary.

- Part 2: prior treatment with anthracyclines with a cumulative dose of doxorubicin of
greater than 400 mg/m2, epirubicin dose of greater than 800 mg/m2, or the equivalent
dose for other anthracyclines.

- Parts 1+2: Subjects with bone as the only site of disease.

- Parts 1+2: Active uncontrolled or symptomatic central nervous system (CNS)
metastases, as indicated by clinical symptoms, cerebral edema, and/or progressive
growth. Subjects with a history of CNS metastases or cord compression are allowable
if they have been considered definitively treated and are off anticonvulsants and
steroids for at least 4 weeks before the first dose of test article.

- Parts 1+2: Any other cancer within 5 years prior to screening with the exception of
adequately treated cervical carcinoma in situ, or adequately treated basal or
squamous cell carcinoma of the skin.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Investigator assessed radiology review

Outcome Time Frame:

until documented Progression of Disease

Safety Issue:


Principal Investigator


Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

December 2008

Completion Date:

December 2013

Related Keywords:

  • Breast Cancer
  • solid tumor
  • erbB2+ breast cancer
  • prior Herceptin
  • metastatic
  • Breast Neoplasms



Investigational SiteCleveland, Ohio  44195
Investigational SiteDuarte, California  91010-3000
Investigational SitePhiladelphia, Pennsylvania  19111
Investigational SiteNew York, New York  10032
Investigational SiteSan Antonio, Texas  78229
Investigational SiteOcala, Florida  
Investigational SiteFairhope, Alabama  36532
Investigational SitePost Falls, Idaho  83854
Investigational SiteLafayette, Indiana  47905
Investigational SiteSt. Louis, Missouri  63110